Resource Type: Webinar

Biannual Meeting

Webinar

Presented on: June 16, 2026

How do leading organizations turn plain language from an aspiration into everyday practice? In this June 2026 MRCT Center webinar, three users of the Clinical Research Glossary share how they put it to work, from global pharma to grassroots patient advocacy.

The Clinical Research Glossary is a free, publicly available resource that translates complex clinical research terms into clear, plain-language definitions. It empowers patients, participants, and the public to make informed decisions about their care and research participation. Developed by the MRCT Center with a diverse, multi-interest-holder workgroup, its definitions have been part of the CDISC global data standards since 2023.

This session highlights real-world adoption and impact, followed by a panel discussion and audience Q&A.

Speakers

• Anna Subrizi, Senior Director, Patient Empowerment, Bristol Myers Squibb. How the Glossary is embedded in BMS’s Universal Patient Language (UPL) program and used across teams for plain language summaries, informed consent forms, and patient materials.
• Sudipta Chakraborty, PhD, Head, Health Literacy & Plain Language Center of Excellence, Biogen. How the Glossary became the exclusive reference for Biogen’s Plain Language Glossary 2.0 and anchors a cross-functional content reuse initiative.
• R. Bernard Coley, Co-Chair, Special Interest Group – Black Diaspora; Care Partner and Research Advocate; recipient of the 2026 World Parkinson Coalition Robin A. Elliott Community Service Award. How the Glossary supports community education, including the Black Parkinson’s Disease Summit.

Moderator: Sylvia Baedorf Kassis, Program Director, MRCT Center

What’s covered

• The MRCT Center and its ongoing commitment to health literacy
• The Clinical Research Glossary and the collaboration with CDISC
• The 2026 public review (June 12 to July 13): 27 definitions up for review, 24 new and 3 updated
• Enterprise use cases from Bristol Myers Squibb and Biogen
• Community and advocacy use cases in Parkinson’s disease education
• Panel discussion and audience questions

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Related Resources

Public Review is a Critical Part of the Clinical Research Glossary process.

Part of being a CDISC global plain language standard means all new terms and definitions, plus change requests we received throughout the year, go through a public review process.

Public Review of the Clinical Research Glossary happens every June. Public Review is now open: June 12 – July 13, 2026

After definitions are developed by the Clinical Research Glossary team, Public Review ensures the definitions get an extra review by people who were not involved in the project. This helps us be more confident that the definitions are clear and easy to understand.

Help us spread the word about Public Review! Click here for the Media Kit.

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Send us your feedback using the MRCT Center Public Review process.

• The MRCT Center’s process uses a simple survey to collect feedback.
• This process will not require reviewers to create an account, but we do ask for name, organization and email address. Collecting this information allows us to validate the entry and follow-up with each person to let them know how the comment was addressed.
• You can send us feedback on already posted definitions all year round and suggest new words for us to consider whenever you want. Click here to contact us.

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The CDISC Public Review process is also an option if you know how to use JIRA

CDISC has kindly provided video instructions here.

How to Submit Comments on Glossary Definitions via JIRA

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Baedorf Kassis S, White S, & Bierer B. (2022). Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research community. Journal of Clinical and Translational Science, 1-20. doi:10.1017/cts.2022.12

Follow the MRCT Center on LinkedIn
Implementing the Clinical Research Glossary: How to Attribute the MRCT Center

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Other On-Demand Glossary-related webinars

Applied Health Literacy: Using Teach-Back in Conversations about Clinical Research

Your Voice, Global Impact: Join the Clinical Research Glossary’s Annual Public Review Process

The Clinical Research Glossary: New Words, New Opportunities

A Global Standard For Plain Language In Clinical Research: MRCT Center And CDISC Collaboration

Webinar

Presented on: May 18, 2026

This webinar, the fourth in the MRCT Center’s AI Digital Twins and Synthetic Data series, focused on data provenance and quality, model validation, and the emerging infrastructure needed to support the clinical and regulatory adoption of these technologies. Panelists explored how to evaluate whether the models used are credible, whether the data underlying them are reliable and traceable, and whether the outputs can be verified and validated for use in regulatory and clinical decision-making. They also discussed what it means for a model to be “fit for purpose,” how definitional differences among these technologies shape regulatory review, and how clinicians, sponsors, reviewers, and regulators may use, interpret, and deploy these tools.

Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tina Morrison, VP, Scientific Strategy, EQTY Lab | Chao-Yi Wu, Assistant Professor of Neurology, Massachusetts General Hospital

Moderator: Barbara Bierer, Faculty Director, MRCT Center

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Related Resources

Deploying Digital Twins and Synthetic Data in Evidence Generation

AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

AI Digital Twins and Synthetic Data: Application to Clinical Trials

Framework for Review of Clinical Research Involving AI

A Framework for AI Adoption and Oversight in Clinical Research

Webinar

Date: May 7, 2026

The MRCT Center, CANTRAIN, and EUPATI hosted a webinar to unveil the results of the JTF-Patient Partner Project. This collaborative effort integrated patient and caregiver expertise directly into the JTF Framework, bringing together patient partners, academic researchers, study staff, industry representatives, and others to reimagine what patient partnership within clinical research teams should entail.

The proposed update includes a supplement focused on operationalizing patient partnership in clinical research. The results are both actionable and aspirational – a blueprint for building more skilled, inclusive, and equitable research teams that generate more responsive and impactful outcomes.

Related Resources:

• Joint Task Force for Clinical Trial Competency
• JTF Framework: Domains and Leveled Core Competencies
• Workforce Development: Opportunities to Engage and Retain Talent in Clinical Research

Webinar

Presented on: March 19, 2026

What does it take to deploy digital twins and synthetic data in clinical evidence generation — and what do regulators expect when you do?

In this third webinar in the MRCT Center’s Digital Twins and Synthetic Data series, a multidisciplinary panel examines the real-world application of these technologies across the clinical trial lifecycle. The discussion covers evidence quality and validation, regulatory benchmarks, model transparency, and the evolving landscape of FDA and EMA expectations. Panelists draw on experience spanning machine learning, FDA policy development, and drug development leadership to offer practical, grounded perspectives on what adoption looks like today — and where the field is headed.

Topics include:

• Defining digital twins and synthetic data: key distinctions and appropriate uses
• Reducing control arms and enhancing statistical power in randomized and single-arm trials
• Applications across rare disease, oncology, and common conditions
• Machine learning vs. traditional statistical approaches: complementary, not competing
• Regulatory acceptance: FDA draft guidance, EMA qualification of PROCOVA, and engagement strategies
• Model evaluation benchmarks and performance validation across development phases
• Cultural and organizational barriers to adoption — and how to address them

Panelists: Daniele Bertolini, Principal Machine Learning Scientist, Unlearn.AI | Tala Fakhouri, VP Consulting AI & Digital Policy and Real World Evidence, Parexel | Karen Smith, Board Director, Context Therapeutics, Skye Bioscience, and Sangamo Therapeutics

Moderator: Barbara Bierer, Faculty Director, MRCT Center

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Related Resources

AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research

AI Digital Twins and Synthetic Data: Application to Clinical Trials

Framework for Review of Clinical Research Involving AI

A Framework for AI Adoption and Oversight in Clinical Research

Webinar

Presented on: December 9, 2025

Hosted by the MRCT Center, in collaboration with Equitable Access to Clinical Trials (EACT), a project convened by LUNGevity Foundation.

Clinical trials are vital to advancing medical knowledge and care, yet participation can impose significant financial burdens on participants and their families—from travel and time away from work to uncovered medical and ancillary expenses.

This webinar examined the sources and impact of these costs and highlighted emerging strategies to reduce financial hardship for research volunteers. Presenters also introduced tools, checklists, and other resources developed through the EACT Project, a collaborative forum advancing financial neutrality in clinical research participation.

Panelists

• Dr. David Gerber, Co-Director, Simmons Comprehensive Cancer Center Office of Education and Training; Professor, University of Texas Southwestern Medical Center
• Wendy K.D. Selig, Founder and CEO, WSCollaborative

Moderator
Dr. Barbara Bierer, Faculty Director, MRCT Center

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Related Resources

EACT Project Resources

• EACT Project website

• Advancing Equitable Access to Clinical Trials- Eliminating the Financial Burden for Participants

• Industry Sponsors Best Practices Webinar

• Tax and Legal Considerations for Compensation Programs for Clinical Trial Participants

• Participant needs assessment and discussion guide

• Engaging with Sponsors About Financial Support Programs for Participants

• Negotiating with Sponsors Checklist

• Participant Needs Assessment Checklist

• Site Personnel Webinar

Financially challenged and underinsured populations

Webinar

Presented on: November 18, 2025

This webinar focused on real-world examples and lessons learned from deploying synthetic data and digital twins across therapeutic areas.

Key Topics:

• Reducing the size of control arms 
• Enhancing Bayesian statistical analysis 
• Supporting single-arm trials 
• Optimizing the design of future trials 

Panelist: Daniele Bertolini, Machine Learning Scientist at Unlearn.ai.

Moderator: Barbara Bierer, Faculty Director at the MRCT Center

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Related Resources

AI Digital Twins and Synthetic Data: Application to Clinical Trials

Framework for Review of Clinical Research Involving AI

A Framework for AI Adoption and Oversight in Clinical Research

Webinar

Presented on: November 4, 2025

Long-term follow-up (LTFU) studies of gene therapy recipients are crucial for understanding the overall benefit-risk profile of these innovative products. However, LTFU studies are challenging to design, conduct, and execute, and pose significant burdens on both patients and sponsors.

In September 2024, the MRCT Center launched an LTFU Working Group. The committee comprises patients, as well as representatives from patient advocacy organizations, industry sponsors, academic medical centers, clinical research organizations, and human oversight protection organizations, each bringing diverse perspectives and complementary scientific, medical, regulatory, and ethical expertise.

On November 4, 2025, the MRCT Center released the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies as a draft for public comment. The Toolkit provides practical guidance regarding best practices for LTFU studies for both investigational and approved gene therapies. It aims to balance the generation of critical long-term safety and efficacy data with the need to reduce burdens placed on participants, caregivers, sponsors, and investigators.

This webinar introduced the Toolkit’s 𝘀𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲 𝗮𝗻𝗱 𝗰𝗼𝗻𝘁𝗲𝗻𝘁𝘀, including:
🔹 𝗚𝘂𝗶𝗱𝗶𝗻𝗴 𝗣𝗿𝗶𝗻𝗰𝗶𝗽𝗹𝗲𝘀
🔹 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗥𝗲𝗰𝗼𝗺𝗺𝗲𝗻𝗱𝗮𝘁𝗶𝗼𝗻𝘀
🔹 𝗟𝗼𝗼𝗸𝗶𝗻𝗴 𝗙𝗼𝗿𝘄𝗮𝗿𝗱

It also highlighted additional practical resources:
🔹 𝗞𝗲𝘆 𝗱𝗲𝘀𝗶𝗴𝗻 𝗲𝗹𝗲𝗺𝗲𝗻𝘁𝘀 of LTFU studies for FDA-approved gene therapies
🔹 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲
🔹 𝗚𝗹𝗼𝘀𝘀𝗮𝗿𝗶𝗲𝘀 𝗮𝗻𝗱 𝗯𝗮𝗰𝗸𝗴𝗿𝗼𝘂𝗻𝗱 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 on types of LTFU studies

𝗠𝗼𝗱𝗲𝗿𝗮𝘁𝗼𝗿:
Carolyn Riley Chapman, PhD MS – Lead Investigator, Brigham and Women’s Hospital; Member of the Faculty, Harvard Medical School

𝗣𝗮𝗻𝗲𝗹𝗶𝘀𝘁𝘀:
Durhane Wong-Rieger, PhD – President and CEO, Canadian Organization for Rare Disorders
Barbara Isquith Arone, MS – Vice President, Medical Affairs Category Lead, IQVIA
Patrick Cullinan, PhD – Head of Medical Writing and Transparency, Adverum Biotechnologies

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Related Resources

Cell and Gene Therapies

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postapproval-methods-capture-safety-and-efficacy-data-cell-and-gene-therapy-products

Patient-Centered Long-Term Follow-Up for Gene Therapies

Innovative Approaches for Gene Therapy Long-Term Follow-Up

Webinar

Presented on: October 30, 2025

On October 30, the MRCT Center hosted a webinar on Applied Health Literacy: Using Teach-Back in Conversations About Clinical Research. The session focused on how the Teach-Back method can improve participant understanding, support safe and equitable clinical research, and strengthen communication throughout the research process. The recording, slides, and a list of resources discussed during the session are provided below.

Overview

The webinar reviewed the essential elements of the Teach-Back method and discussed how study teams can simplify complex information, confirm understanding, and foster dialogue with participants and caregivers during recruitment, informed consent, and ongoing study engagement. Presenters emphasized the role of Teach-Back in enhancing clarity, reducing burden, and supporting participant-centered, high-quality research.

Speakers

• Mary Ann Abrams, MD, MPH – Physician and Health Literacy Expert, Nationwide Children’s Hospital; Assistant Professor of Pediatrics, The Ohio State University College of Medicine
• Stephanie Shepherd, MBOE, BSN, RN – Clinical Educator, Nationwide Children’s Hospital
• Marian Ryan, PhD, MA, MPH – Chief Policy & Research Officer, Institute for Healthcare Advancement (IHA)

Moderator

• Sylvia Baedorf Kassis, MPH – Program Director, MRCT Center

What the Session Covered

• How Teach-Back supports participant comprehension, autonomy, and safety
• Approaches to explaining complex study information in accessible, plain language
• Strategies for confirming understanding in an ethical, respectful, and culturally responsive manner
• Practical examples of how to integrate Teach-Back across recruitment, informed consent, and study follow-up processes

Additional Resources

Return of Aggregate Results to Participants Guidance Document Version 3.1

Return of Aggregate Results to Participants Toolkit Version 3.1

MRCT Center Health Literacy Website

Clinical Research Glossary

Health Literacy Resources for IRBs
Health Literacy Best Practices
https://health.gov/our-work/national-health-initiatives/healthy-people/healthy-people-2030/health-literacy-healthy-people-2030
https://nces.ed.gov/naal/health.asp
https://www.ahrq.gov/sites/default/files/wysiwyg/health-literacy/dhhs-2008-issue-brief.pdf
http://justplainclear.com/en
http://www.plainlanguage.gov/whatisPL/definitions/eagleson.cfm
https://Teachbacktraining.org
https://www.Teachbacktraining.org/OrganizationalHealthLiteracyGuidebook2
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants

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Webinar

Presented on: September 30, 2025

This webinar focused on how to responsibly integrate AI into the design, conduct, and oversight of clinical research, introducing two rapidly evolving applications:

• Digital twins – simulated models of individual patients designed to predict disease trajectories and treatment responses, with the potential to enhance statistical power, optimize design, and reduce the number of participants assigned to control arms.
• Synthetic data – artificially generated datasets that mirror the statistical properties of verified clinical data, with potential use in trial design, conduct, analysis, and regulatory submissions.

Panelist: Daniele Bertolini, Machine Learning Scientist at Unlearn.ai.

Moderator: Barbara Bierer, Faculty Director at the MRCT Center

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Related Resources

Framework for Review of Clinical Research Involving AI

A Framework for AI Adoption and Oversight in Clinical Research